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"Hello Darkness , my old friend....C' MON MAN
I was referring to this "Late data" .In your post.....( which I read as a heads up). If that is not what was meant...then disregard .
IMO, if there is ONLY ONE GLITCH ...THAT WOULD BE IMPRESSIVE.
The exchanges' next holiday closure is on Monday, Dec. 26, for Christmas, because the holiday falls on a Sunday this year.
Riddle me this???
Will 2023 be the year the FDA FINALLY RECOGNIZES that the "Amyloid Plaque Thesis", as a causal path for AD is DEAD???
If, Y, then , what will they claim is the REAL CAUSE? Will they connect the DOTS between CAUSE and AD.
Thank you...all the best.
G328
As falconer mentioned, ANY Mention in "Nature" is the real thing in connected-premier publication. So, the Dr.M. work- science presentation to be done soon in the January (BIG DEAL) may NOT be just a coincidence , B/C as we ALL KNOW..."This Kind of Shat happens all the time".
So MANY DOTS, SO LITTLE TIME.
Big Storm in NE US Thurs-Friday. Do not be surprised if WS slows (way) down on 12/22-23 due to winds/temps/snow...other.
Hoskuld
wolf7
Hope to see the day when facts on systemic corruption in CNS BP make it into the daylight.
ARE WE THERE YET???
Maybe a new start...
8.64+0.29 (+3.47%)
At close: December 16 04:00PM EST
8.99 +0.35 (+4.05%)
Pre-Market: 09:07AM EST
How long will researchers beat this long dead horse and ignore every contradiction shown after decades of failed trials?
https://www.alzra.org/blog/surprising-new-theory-explains-what-might-cause-alzheimers/
Hoskuld
What a great story.
IMO, RWD-RWE is buy far the most powerful/convincing tool-suite-evidence producer available to CNS disease patients. Yes, The abstraction of detailed clinical data is needed (we get that) but in the end we are helping patients and their families. It just does not get any better then that.
They are not anecdotes, they a walking -talking patients w/families and healthy lives to lead...We are helping to make that happen
Kittykitty
Blarcas
I love the idea that these are all(each one) legitimate , high quality, management accomplishments that the AVXL ops and management teams can be proud of, along w/the rest of us.
Which one of the AVXL BIG SHOES that are about to drop will trigger the biggest reaction??
A. Peer reviewed paper?
B. Parkinson's OLE report?
C. RSD report-FDA action?
D. Partnership?
E. Other-Examples?
WGT.
We are in the RED ZONE , many people are counting on us, even if they do not know that yet.
Which one of the AVXL BIG SHOES that are about to drop will trigger the biggest reaction??
A. Peer reviewed paper?
B. Parkinson's OLE report?
C. RSD report-FDA action?
D. Partnership?
E. Other-Examples?
WGT.
FYI..Full reply text from JKS...
Thanks JKS for your informed/insightful response . Based on your comments I would conclude there are more-better control systems and validated process controls in place in OUR WW trials program.
JKS3
abew4me
Thanks Red Shoulder, this text is exactly consistent w/my post of a last week here. AVXL would have done a lot of hard work behind the curtain in order to fully comply w/these requirements , asIi said. Additional interfaces w/ CRO's would have also been done w/ a V&V interface for all trial action and information.
If all this work was completed and verified accordingly then (IMO) the WW trial data is going to be witnessed as , "Bullet Proof". AND, the CRO-AVXL team are to be commended . WELL DONE.
from Red Shoulder post:
XenaLives
JkS3, you may have this info or know where it should be.
AVXL are doing/completeing trials in a number of different countries simultaneously. Do you know who are the CRO's being used in each? Do you know if AVXL have precertitied/validated these CRO's for required crednetials proior to doing the trials. My guess is multiple CRO's in several countries, using complex technology and S/W-H/W systems starts to get to be a complexity -management issue very quickly. Simple things like REv controls and records management protocols/requirements can get hard to do while running at full speed.
So, keeping all the CRO's on the same program-time page, having evidence of each validated SW-HW system (see records/change control) are all fundamental to passing FDA-(in country) certifcation requirements.
Doing what must be done WW while trials are running AND while keeping FDA (other) certification requirements WW is a big job. I won't even mention time compression and criticality of each module or rev. controls.
Mind boggles w/trying to know where to start and how to know adequate CRO-Regulatory bodies controls are in place. Never mind doing all this against a time compressed schedule.
Any ideas if all that was done by respective in country CRO's in a AVXL program coordinated manner or if AVXL staff did such from a central control point?
TIA.
Exccellent point. He would not of course.
Mikesc
WS and BP are paid for point solutions, only. Does it work (Y/N)? If N then no value. CNS diseases do not fit that mental model, consequently we end up w/the AD, MS, MD..etc partial solution-payback -investment model. Investment is rewarded for BIG results which CNS diseases generally do not conform w/in a serial manner. No credit is given by WS for partial solutions...THEY DO NOT GET IT.
crescentmotor
I am encouraged by the spirit and languege here. AVXL needs to get a clear messge out which speaks to all AD-and CNS diseased families and clinicians. Evryone else will figure out what has just happened soon enough. AVXL has a safe and effective CNS MOA- treatment portfolio with evidnce of efficacy never seen.
We must quickly package an effective message and work with the FDA other regulatory bodies and 2nd, 3rd parties WW to move forward quickly. We are not finished but we are clearly the scientific -clinical leaders. We need to get our commercial story cleaned up and go sell it ASAP before our opponents figure out what just happened.
The scientific truth will take care of the rest .
sab63090
Lets all get synched up on this point. IMO, the sp attack we have been through is part of a planned combo (FDA/BP) move. BP/WS are scared shatless. The wide systemic consequences of an AVXL strong competitive CNS disease treatment portfolio (such as ours) linked to A Strong AVXL CNS upstream bio-med portfolio w/ efficacy will gut the existing revenue system that much WS BP is dependent on.
Is AVXL being set up for a low ball buyout ?
If you are an AVXL owner and have been paying attention then YOU MUST READ THIS PR. IMO, This explains everything that happened today (SP$$$) AND WHY? W/S and the FDA-are corrput and we all payed the price for that today. Hang in, our day will come.
https://www.zacks.com/stock/news/2025501/anavexs-avxl-lead-alzheimers-drug-meets-study-goal
We (me) have not understood the depth of the AMYLOID PLAQUE $$$ AND TIME spent over 3+ decades by our WS -BP competitors. There is absolutely NO WAY they could allow AVXL to win today. This is a far bigger issue than I thought was possible in a regulated industry. IMO, it is also CLEAR that FDA was at least silent(when they should have been commenting on AVXL results). WOW. Just connect the DOTS.
Hang in there AVXL TEAM, we are about to blow the lid off this entire 30 year cover. This knowledge also explains why our SP did what it did while the BP-SCAMMERS watched. IMO, this was all planned and AVXL team just walked right into a WS ambush.
CKENT...EXACTLY CORRECT...WGT...this explains why WS reacted as they did to our data...